Organization Domain of the Citeline Maturity Model for Clinical Trial Disclosure
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Article 10 in our Maturity Model series
The organization domain focuses on the structural elements that support effective clinical trial disclosure. It encompasses roles and responsibilities, cross-functional collaboration, and organizational alignment. A properly coordinated organization ensures efficient disclosure processes, clear accountability, and adaptability to evolving regulatory requirements.
A well-structured organizational approach to clinical trial disclosure ensures consistency, efficiency, and compliance across all transparency efforts. Clear roles, responsibilities, and reporting lines enable effective decisionmaking and accountability, reducing the risk of missed deadlines or incomplete disclosures. Strong cross-functional collaboration facilitates the smooth flow of information and expertise among departments, enhancing the quality and timeliness of disclosed data. An optimized organizational structure allows for better resource allocation and scalability, enabling sponsors to adapt to changing regulatory landscapes and growing disclosure requirements. Finally, a mature organizational approach fosters a culture of transparency, aligning disclosure activities with broader corporate values and building trust with patients, healthcare professionals, and regulatory bodies:
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Thomas Wicks
Head of Transparency Operations, Citeline
ライフサイエンス分野で20年以上の経験を持つ戦略リーダーであり、現在はCitelineの透明性業務責任者を務めています。業界をリードするTrialScopeの情報開示ソリューションの戦略を指揮し、透明性に関する深い知識と実績を持っています。
トーマスは、情報開示要件や透明性のトレンドについてのオピニオンリーダーとしても高く評価されており、これまでに60以上のカンファレンスで講演し、40以上の出版物を執筆しています。また、裁判の透明性を尊重するソリューションを加速させることを使命とし、チームに力を与えることに情熱を注いでいます。